Zytiga (Generic)

This medication is used to treat prostate cancer. Abiraterone belongs to a class of drugs known as anti-androgens (anti-testosterone). Testosterone, a natural hormone, helps prostate cancer to grow and spread. Abiraterone works by blocking the production of testosterone, thereby slowing the growth and spread of prostate cancer.

This medication should not be given to women or children.

Read the Patient Information Leaflet if available from your pharmacist before you start taking abiraterone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Different brands of this medication may have different dosing directions. Do not change brands of this medication without your doctor's direction.

Take this medication by mouth on an empty stomach (at least 1 hour before or 2 hours after food) as directed by your doctor, usually once daily. Taking abiraterone with food greatly increases the amount of this drug in your body and increases the risk of side effects.

Swallow whole. Do not crush or chew before swallowing. Pregnant women should wear gloves if handling the tablets. If the tablet is crushed or broken, women who are pregnant or who may become pregnant should not handle it or breathe the dust from it (see also Precautions section).

The dosage is based on your medical condition, lab results, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not stop any medications for your prostate cancer unless told to do so by your doctor. Stopping your medications could allow the cancer to spread more rapidly.

Tell your doctor if your condition persists or worsens (such as urination becomes more difficult, bone pain increases).

Headache, hot flushes, joint pain, heartburn or cold-like symptoms may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.

Tell your doctor right away if you have any serious side effects, including: increased urination, painful urination, muscle cramps/weakness, leg pain, swelling in legs/feet, bone fractures.

Get medical help right away if you have any very serious side effects, including: chest pain, feeling short of breath while at rest, fast/irregular heartbeat, severe dizziness, fainting, symptoms of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking abiraterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: previous heart attack, high blood pressure, liver problems.

Abiraterone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using abiraterone, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using abiraterone safely.

Using corticosteroid medications for a long time along with abiraterone can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. If you will be using this medication for a long time, carry a warning card or medical ID bracelet that identifies your use of this medication.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

This medication should not be used in women, especially during pregnancy or breast-feeding. It may harm an unborn or breast-feeding baby. Women who are pregnant or breast-feeding should avoid touching or accidentally taking this medication. Consult your doctor for more details.

Because it is unknown if abiraterone passes into semen, men who use this drug and have sex with pregnant women must use a latex condom during all sexual contact, even if they have had a vasectomy. Men who use this drug and have sex with women of child-bearing age should use a latex condom and another reliable form of birth control (such as diaphragm with spermicide) during all sexual contact. Continue using reliable form(s) of birth control as directed until 3 weeks after abiraterone treatment has been stopped.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of abiraterone from your body, which may affect how abiraterone works. Examples include rifamycins (such as rifabutin), drugs used to treat seizures (such as carbamazepine, phenytoin, phenobarbital, primidone), St. John's wort, among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. If you miss more than one dose, talk to your doctor right away.

Do not share this medication with others.

Laboratory and/or medical tests (such as blood pressure, potassium levels, liver function tests, blood PSA test) should be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Consult your doctor for more details.